--- title: "AstraZeneca pulls Andexxa from US market after post-marketing fatalities" type: "News" locale: "zh-CN" url: "https://longbridge.com/zh-CN/news/270479078.md" description: "AstraZeneca has withdrawn its anticoagulant therapy, Andexxa, from the US market following FDA concerns over severe thromboembolic events linked to the drug. The decision comes after post-marketing studies revealed increased risks, leading to fatalities. AstraZeneca voluntarily withdrew Andexxa's biologics license application and will cease its sale and manufacture in the US by December 2025. The drug remains conditionally approved in Europe and the UK, but its future approval is uncertain due to unfavorable safety data." datetime: "2025-12-22T10:38:19.000Z" locales: - [zh-CN](https://longbridge.com/zh-CN/news/270479078.md) - [en](https://longbridge.com/en/news/270479078.md) - [zh-HK](https://longbridge.com/zh-HK/news/270479078.md) --- > 支持的语言: [English](https://longbridge.com/en/news/270479078.md) | [繁體中文](https://longbridge.com/zh-HK/news/270479078.md) # AstraZeneca pulls Andexxa from US market after post-marketing fatalities AstraZeneca has pulled Andexxa, an emergency coagulant, from the US market following the FDA’s request. Image credit: andreaaaaaaaaa via ShutterStock.com. AstraZeneca has pulled its anticoagulant therapy, Andexxa (recombinant coagulation factor Xa), from the US market after patient fatalities. This follows rising concern from the US Food and Drug Administration (FDA) around Andexxa’s benefit-risk profile, as post-marketing studies have revealed that the coagulant can put patients at risk of serious or fatal thromboembolic events. ### Go deeper with GlobalData - ![ReportsLogo](/wp-content/themes/goodlife-wp-B2B/assets/img/report.png) Reports #### NPVM: AstraZeneca Plc's AZD-8205 - ![ReportsLogo](/wp-content/themes/goodlife-wp-B2B/assets/img/report.png) Reports #### NPVM: AstraZeneca Plc's Datopotamab deruxtecan ##### Go deeper with GlobalData The gold standard of business intelligence. Find out more #### Discover B2B Marketing That Performs Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms. Find out more During the confirmatory Phase III ANNEXA-I study (NCT03661528), which was conducted after Andexxa was granted accelerated approval, thrombosis incidence in the treatment group was 14.6% versus 6.9% in the usual care control arm. There were also six deaths linked to thrombotic events after 30 days in the Andexxa arm, while two patients died in the control cohort. Following a meeting between members of the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee to discuss these results, the agency left Andexxa’s US market future in limbo back in December 2024, as it refused to fully approve the drug. AstraZeneca has now voluntarily withdrawn Andexxa’s biologics license application (BLA) and will no longer sell or manufacture Andexxa in the US after 22 December 2025. AstraZeneca originally obtained the rights to Andexxa after its $39bn acquisition of Alexion Pharmaceuticals in 2021. Alexion has previously acquired the drug’s original developer, Portola Pharmaceuticals, in a $1.4bn buyout in 2020. The coagulant was previously approved on an accelerated basis for the reversal of life-threatening or uncontrolled bleeding triggered by anticoagulants Eliquis (apixaban) and Xarelto (rivaroxaban) back in 2018. When it was on the US market, a boxed warning for thromboembolic events was required. GlobalData Strategic Intelligence # US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Currently, Andexxa is still approved for use by the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare Regulatory Agency (MHRA) on a conditional basis. While it is currently unknown what stance other global regulators will take on Andexxa’s benefit-risk profile, the unfavourable post-marketing safety data could see the therapy fail to gain full approval. Andexxa pulled in $219m in sales globally in 2024, with $81m of this profit coming from the US. ## Pharmaceutical Technology Excellence Awards - Nominations Closed Nominations are now closed for the Pharmaceutical Technology Excellence Awards. A big thanks to all the organisations that entered – your response has been outstanding, showcasing exceptional innovation, leadership, and impact. **Excellence in Action** Awarded the 2025 Pharmaceutical Technology Excellence Award for Business Expansion in Integrated Manufacturing, Upperton Pharma Solutions is rapidly expanding its UK GMP and sterile manufacturing footprint. Find out how Upperton’s integrated CDMO model helps pharma companies move from early development to clinical and niche commercial supply with fewer handovers and faster timelines. 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